Pathology specimens on slides, such as Pap smears, are examined under microscopes for various events of interest such as possible cancer cells and the like. The examination focuses primarily on a review of the cells of the specimen, with notation of events of interest at specific locations in the specimen on the slide. Separate and independent review of the examination, and any analysis which accompanied the initial screening examination, particularly for quality control purposes and for verification of findings, should take into account the thoroughness with which the original microscope examination was conducted, though this has been difficult to achieve.
The original screening and analysis should include four basic types of information which are: 1) identifying information to tie the specimen of the slide to a particular source or patient, 2) information which may be useful to the person analyzing the slide, 3) the location and characterization of specific events, found by screening the slide, and 4) a history of the screening process including whatever quality control parameters may have been utilized. However, such information is not amenable to recordation on the slide itself except on the most rudimentary levels of identifying information in the form of handwritten, typed or printed labels, or bar-coded labels. Information regarding the actual slide specimen analysis is kept in computer files, in paper records, on tape recorded narrations, or by other means, all of which are maintained at locations separated from the individual slides.
To preserve a modicum of proximate information it has been the practice to directly mark events of interest in such a manner which facilitates ready review. A common method of such marking, is ink dot placement at events of interest. Some of these ink dot placements are effected by sophisticated mechanized and computerized means. However, despite the degree of sophistication, this method is messy, inaccurate and time consuming. Furthermore, ink dots typically cover an entire field of view, which may contain hundreds of cells and the dots can obscure the field of view, either directly or with smearing of the ink.
Alternatively, various relocation methods and expedients have been utilized as well as other means to either actually record the original analysis or to map out, by slide coordinates, the areas of specific interest. Examples of such recordations include optical video taping, and computerized specimen mapping and correlative computer generated imaging. Many of such alternative methods, including the computer generated slide examination representation, as described in U.S. Ser. No. 08/089,243, filed on Jul. 19, 1993, and owned by the same assignee as the present invention (the disclosure of which is incorporated herein by reference thereto), involve recordation on external media (e.g. video tape and magnetic disks). Such methods work well, provided that the pathology slides are proximate in time and place wherein the external media are readily available for review and analysis, with correlation to the slide. However, after a lapse in time and the transfer of the slide to remote locations, typically for consultation, research and testing purposes, the ability of the slide to be properly analyzed, is severely retarded, short of another review and scanning of the slide, in the absence, loss or other unavailability of the externally separately stored screening analysis.
Currently, direct marking of slides is restricted to the ink dot placement described above and handwritten, printed, or bar coded labels which can be used to, at most, identify slides but which are incapable of retaining vital patient information, such as medical history which may be of critical importance for the screener in making an accurate diagnosis, such as distinguishing reparative reactions from malignancy. Though such information may be contained in the laboratory's computerized information system (LIS), it may not always be available at remote testing or reviewing locations. Further marking of the slide is restricted by the very nature of the slide and specimen, wherein marking, even on the obverse side of the slide, interferes with proper viewing of the specimen (obverse-side marking detrimentally blocks light from illuminating portions of the specimen).
It is important that at least this criterion be evaluated in order to assure a competent initial screening, i.e., a valid demonstration that the entire slide has been screened so that no important events have been missed.
In addition, to assure the validity of analysis of a screening it is necessary to demonstrate that the screener is able to locate noteworthy events on the slide; and that the screener has been able to accurately characterize such events.
As currently used, the label is of insufficient size to record the history of the screening, and ink dot placement alone is deficient in accurately providing such information.
Various devices and means are capable of evaluating all of the above and storing the information in the LIS or on PCMCIA cards or diskettes. However, as described above, the information may not be readily available when the slide is being reviewed, for example, when a patient has a positive finding on a PAP smear and the laboratory recalls PAP smears on the patient from prior years to determine whether cancer cells were missed.
It is therefore an object of the present invention to provide a means for providing a pathology slide with both specimen and integral review and interpretation thereof, making it viably reviewable without any separate original screening information.
It is a further object of the present invention to provide the pathology slide with high density machine recordable and readable media capable of recording both identification information relative to the specimen and review interpretation of the slide for recall and correlation to the actual specimen.
It is yet another object of the present invention to provide a slide analysis system which includes a slide having machine recordable media thereon, with high information recordation capacity, but which strip does not interfere with slide analysis.